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Focused fluid for analysis of urine formed components - NMPA Registration 吉械注准20242400006

Access comprehensive regulatory information for Focused fluid for analysis of urine formed components in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 吉械注准20242400006 and owned by Jilin Base Egg Biological Technology Co., Ltd.. The device was approved on January 25, 2024.

This page provides complete registration details including registrant information, province location (Jilin), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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NMPA Official Data
Class II
吉械注准20242400006
Focused fluid for analysis of urine formed components
尿有形成分分析用聚焦液
NMPA Registration Number: 吉械注准20242400006
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Intended Use
English

It is used to determine the focal plane position of the microscopic imaging system of the urine tangible analysis instrument.

中文

用于尿有形分析仪器显微成像系统焦面位置的确定。

Device Classification
Device Class
Class II
Model Specifications
1×20mL、1×60mL、1×125mL
Approval Department
Jilin Provincial Drug Administration
吉林省药品监督管理局
Registration Information
Registration Number
吉械注准20242400006
Approval Date
January 25, 2024
Expiry Date
January 24, 2029
Registrant
Name
Jilin Base Egg Biological Technology Co., Ltd.
吉林基蛋生物科技有限公司
Province/Region
Jilin
吉林
Address
No. 1399, Ya'an Road, Beihu Science and Technology Development Zone, Changchun City, Jilin Province
吉林省长春市北湖科技开发区雅安路1399号
Production Facility
Production Address
吉林省长春市北湖科技开发区雅安路1399号
Structure and Composition
English

Porcine red blood cells: 1500 particles/μL~2000 particles/μL

中文

猪血红细胞:1500粒子/µL~2000粒子/µL

Storage Conditions and Expiration
English

Under the condition of 2 °C ~ 8 °C, protect from light, sealed storage, and the validity period is 8 months. After the first opening, it can be stored at 2°C~8°C in the dark, sealed, and can be stable for 30 days.

中文

在2℃~8℃条件下,避光、密封贮存,有效期为8个月。首次开封后,2℃~8℃避光、密封保存,可稳定30天。

Additional Information
Appendix
产品技术要求、说明书